a study to evaluate safety and efficacy of lebrikizumab in participants with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: phase ii, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with copd and a history of exacerbations who are treated with inhaled corticosteroid (ics) and at least one long-acting bronchodilator inhaler medication. this study will be conducted to assess the safety, efficacy, and patient-reported outcome (pro) measures.


Eligibility criteria:
inclusion criteria: * documented history of copd greater than or equal to (\>/=) 12 months prior to visit 1 * post-bronchodilator fev1/fvc less than (\<) 0.70 at visit 1 or 2 * post bronchodilator fev1 \<80% predicted at visit 1 or 2 * documented history of one or more acute copd exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to visit 1 * current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to visit 1) with a history of smoking \>/=10 pack-years (20 cigarettes/day for 10 years) * on inhaled corticosteroids (ics) therapy for \>/=6 months prior to visit 1 * on an eligible bronchodilator medication for \>/=6 months prior to visit 1 * chest x-ray or computed tomography (ct) scan within 6 months prior to visit 1 or chest x-ray prior to visit 2 that confirms absence of clinically significant lung disease besides copd * demonstrated adherence with background copd inhaler medication during screening period * for female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study exclusion criteria: * history of severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection * history of clinically significant pulmonary disease other than copd * diagnosis of alpha-1-antitrypsin deficiency * lung volume reduction surgery or procedure within 12 months prior to visit 1 * supplemental oxygen requirement \>2 liters/minute (l/min) at rest or with exertion * current diagnosis of asthma * participants participating in, or scheduled for, an intensive copd rehabilitation program * maintenance oral corticosteroid therapy * treatment with systemic corticosteroids within 4 weeks prior to visit 1 or during screen period * unstable ischemic heart disease or other relevant cardiovascular disorders * use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (il) or anti-il-4/il-13 therapy) * body weight \<40 kg * any infection that resulted in hospital admission for \>/= 24 hours and/or treatment with oral, intravenous (iv), or intramuscular (im) antibiotics within 4 weeks prior to visit 1 or during screening * upper or lower respiratory tract infection within 4 weeks prior to visit 1 or during screening * active parasitic or listeria monocytogenes infection within 6 months prior to visit 1 or during screening * received a live attenuated vaccine within 4 weeks prior to visit 1 or during screening * active tuberculosis requiring treatment within 12 months prior to visit 1 * human immunodeficiency virus (hiv) or other known immunodeficiency * hepatitis or known liver cirrhosis * aspartate aminotransferase (ast), alanine aminotransferase (atl), or total bilirubin elevation \>/=2.0 x upper limit of normal (uln) during screening * clinically significant abnormality on screening electrocardiogram (ecg) or laboratory tests * history of alcohol or drug abuse * pregnant or lactating